ES2974568T3 - Catheter Needle Capture Safety Locking Device - Google Patents

Abstract

A catheter assembly includes a flexible catheter (22), a needle (12) having a sharp distal tip, the needle (12) disposed in the flexible catheter (22) and moving from a first position exposing the needle (12) to a second position, an outer member (26) that is configured to engage and disengage a catheter hub (14), an inner member (28) disposed in the outer member (26), and a needle shield member (30) disposed in the inner member (28), the needle shield member (30) enveloping at least a portion of the needle (12) when the needle (12) is in the second position. (Automatic translation with Google Translate, no legal value)

Description

DESCRIPTION

Catheter Needle Capture Safety Locking Device

Related applications

This application claims benefit, pursuant to section 119(e) of the U.S.C. 35, of US Provisional Patent Application Serial Number 61/981,223, filed April 18, 2014; of the US Provisional Application

61/981,312, filed on April 18, 2014, and Provisional Patent Application with Serial Number 62/077,760, filed on November 10, 2014.

Field

Various exemplary embodiments of the invention relate to catheters.

Background

Catheter assemblies are used to properly place a catheter into a patient's vascular system. Once in place, catheters such as intravenous catheters can be used to infuse fluids including normal saline, medicinal compounds and/or nutritional compositions into a patient in need of such treatment. The catheters additionally allow the removal of fluids from the circulatory system and monitoring of conditions in the patient's vascular system.

Summary of the invention

The catheter assembly according to the invention is defined by the features of claim 1. Preferred embodiments are defined by the features of the dependent claims.

It is an aspect of the present invention to provide a catheter assembly in which a clip provides protection to the needle but does not lock the catheter hub with the needle guard. Instead, the catheter assembly incorporates an outer needle member, an inner needle member, and a clip disposed on the inner needle member. The outer member locks the catheter hub based on engagement of the opposing member on the inner member to a hole in the catheter hub. The needle guard arrangement can be used with existing catheter connectors and does not require any special features to be provided on the exterior or interior of the catheter connector.

All of the above and/or other aspects of the present invention can be achieved by providing a catheter assembly comprising a flexible catheter, a needle having a sharp distal tip, the needle disposed in the flexible catheter and moving from a first position exposing the needle to a second position, an outer member that is configured to engage and disengage from a catheter connector, an inner member disposed on the outer member and a needle protection member disposed on the inner member, the needle protection member The needle encloses at least a portion of the needle when the needle is in the second position.

The above and/or other aspects of the present invention can further be achieved by providing a catheter assembly comprising a flexible catheter, a needle having a sharp distal tip, the needle disposed in the flexible catheter and moving from a first position exposing the needle to a second position, an outer member configured to engage and disengage from a catheter hub, an inner member disposed on the outer member, the inner member having an opposing member that engages the catheter hub when the needle is in the first position, and a needle protection member disposed on the inner member enclosing at least a portion of the needle when the needle is in the second position, wherein when the needle is in the second position, the inner member moves axially relative to the outer member, causing the opposite member to disengage from the catheter hub and allowing the outer member to disengage from the catheter hub. The above and/or other aspects of the present invention can also be achieved by providing a method (not claimed) for operating a catheter assembly comprising placing a needle having a sharp distal tip into a flexible catheter and in a first position configured to receiving blood, retracting the needle while maintaining blood flow through the flexible catheter, enclosing at least a portion of the needle by a needle guard member in a second position, and moving the needle guard member that It is disposed on an inner member when the needle is retracted in the second position, which causes the inner member to move axially within an outer member and allows the outer member to disengage from the catheter hub.

Other and/or additional aspects and advantages of the present invention will be set forth in the description that follows, or will be apparent from the description, or may be learned by practicing the invention.

Brief description of the drawings

The above aspects and features of the present invention will be more apparent from the description for exemplary embodiments of the present invention taken with reference to the accompanying drawings, in which: FIG. 1 is a perspective view of an exemplary catheter with an attached needle cover.

FIG. 2 is a perspective view of the catheter of FIG. 1 with needle cover removed. FIG. 3 is a perspective view of an exemplary side port catheter and needle cover. FIG. 4 is a side sectional view of the catheter of FIG. 1.

FIG. 5 is a side sectional view of the catheter of FIG. 3.

FIG. 6 is an exploded perspective view of an exemplary needle, a needle guard and a needle connector. FIGS. 7A-D are perspective views of the outer sleeve of the exemplary needle guard of FIG. 6.

FIG. 7E is a top view of the external sleeve of FIG. 6.

FIG. 7F is a right side of the outer sleeve of FIG. 6.

FIG. 7G is a bottom view of the external sleeve of FIG. 6.

FIG. 7H is a front view of the external sleeve of FIG. 6.

FIG. 7I is a rear view of the external sleeve of FIG. 6.

FIG. 7J is a left side view of the external sleeve of FIG. 6.

FIG. 8A is a perspective view of the needle guard connected to the catheter connector.

FIG. 8B is a top view of the needle guard connected to the catheter connector.

FIGS. 9A-D are perspective views of the inner sleeve of the exemplary needle guard of FIG. 6.

FIG. 9E is a top view of the inner sleeve of FIG. 6.

FIG. 9F is a view of the right side of the inner sleeve of FIG. 6.

FIG. 9G is a bottom view of the inner sleeve of FIG. 6.

FIG. 9H is a front view of the inner sleeve of FIG. 6.

FIG. 9I is a rear view of the inner sleeve of FIG. 6.

FIGS. 10A-D are perspective views of the exemplary needle guard clip of FIG. 6.

FIG. 10E is a view of the right side of the clip of FIG. 6.

FIG. 10F is a front view of the clip of FIG. 6.

FIG. 10G is a left side view of the clip of FIG. 6.

FIG. 10H is a top view of the clip of FIG. 6.

FIG. 10I is a bottom view of the clip of FIG. 6.

FIG. 11 is a side sectional view of the exemplary needle guard of FIG. 6.

FIG. 12 is a top sectional view of the exemplary needle guard of FIG. 6.

FIG. 13 is a side sectional view of another exemplary needle shield connected to a catheter hub with an introducer needle extending into the catheter hub.

FIG. 14 is a side sectional view of the exemplary needle guard of FIG. 13 with the needle withdrawn towards the needle guard.

FIG. 15 is a cutaway side view of the exemplary needle guard of FIG. 13 with the inner sleeve removed from the catheter connector and toward the outer sleeve.

FIG. 16 is a cutaway side view of the exemplary needle guard of FIG. 13 with the needle guard removed from the catheter connector.

FIGS. 17A-C illustrate another exemplary embodiment of a needle guard being attached to and then removed from a catheter connector.

FIG. 18 illustrates another exemplary embodiment of a needle guard connected to a catheter connector.

FIG. 19 illustrates another exemplary embodiment of a needle guard connected to a catheter connector.

FIG. 20 illustrates another exemplary embodiment of a needle guard removed from a catheter connector.

FIG. 21A illustrates another exemplary embodiment of a needle shield connected to a catheter connector.

FIG. 21B is an enlarged view of FIG. 21A showing the coupling of the outer sleeve and inner sleeve with the catheter connector.

FIG. 22A is a side sectional view of another exemplary embodiment of a needle shield connected to a catheter connector.

FIG. 22B is the needle protector and catheter connector of FIG. 22A with the needle drawn toward the outer sleeve. FIG. 22C is the needle guard of FIG. 22A separate from catheter connector.

FIG. 23A is a side sectional view of another exemplary embodiment of a needle shield connected to a catheter connector.

FIG. 23B is the needle guard of FIG. 23A with the inner sleeve removed from the catheter hub and a tension member disengaging the closure device.

FIGS. 24A-D are perspective views of an exemplary inner sleeve with an integral clip.

FIG. 24E is a top view of the inner sleeve with an integral clip shown in FIG. 24A.

FIG. 24F is a right side view of the inner sleeve with an integral clip shown in FIG. 24A.

FIG. 24G is a front view of the inner sleeve with an integral clip shown in FIG. 24A.

FIG. 24H is a rear view of the inner sleeve with an integral clip shown in FIG. 24A.

FIG. 24I is a bottom view of the inner sleeve with an integral clip shown in FIG. 24A.

FIG. 25A is an exploded perspective view of an exemplary catheter having a needle guard and a spring return blood control actuator and a septum.

Fig. 25B is a perspective view of the septum of FIG. 25A.

FIG. 26A is a side sectional view of the catheter of FIG. 25A.

FIG. 26B is a side sectional view of the catheter of FIG. 26A with the needle removed.

FIG. 26C is a side sectional view of the catheter of FIG. 26B with a male Luer connector inserted into the catheter connector.

FIG. 26D is a side sectional view of the catheter of FIG. 26C pushing the Luer connector the actuator through the septum.

FIG. 26E is a side sectional view of the catheter of FIG. 26D with the male Luer connector being removed from the catheter connector.

FIG. 26F is a side sectional view of the catheter of FIG. 26E with a male Luer connector removed from the catheter hub.

FIG. 27 illustrates a right side view of another exemplary embodiment of an actuator.

FIG. 28A illustrates a cross-sectional view of the actuator of FIG. 27 in a catheter connector assembly.

FIG. 28B illustrates the cross-sectional view of the catheter hub assembly of FIG. 28A when piercing a septum.

FIG. 28C illustrates a left perspective cross-sectional view of the catheter connector assembly of FIG. 28A when piercing a septum.

FIG. 29A illustrates a cross-sectional view of another exemplary embodiment of a catheter hub assembly.

FIG. 29B illustrates the cross-sectional view of the catheter hub assembly of FIG. 29A when piercing a septum.

FIG. 29C illustrates the left perspective cross-sectional view of the catheter connector assembly of FIG. 29A when piercing a septum.

Detailed description of exemplary embodiments

A catheter 10, as illustrated in FIGS. 1-6, includes a hollow metal introducer needle 12, a catheter hub 14, a needle hub 16, a needle cover 18 and a needle guard 20. The needle cover 18 initially covers the needle 12 and at least a portion of the catheter connector 14. The needle cover 18 can be connected to the catheter connector 14 or the needle connector 16. The needle 12 has a sharp distal end and initially extends through the needle shield 20 and the connector of catheter 14. A flexible catheter tube 22 extends from the distal end of the catheter connector 14, the introducer needle 12 passing through the catheter tube 22. Initially, the needle 12 is exposed (first position, for example) and inserted into a patient's vein. The catheter tube 22 is pushed through the needle 12 and into the vein following the needle 12. After the catheter tube 22 is inserted, the needle 12 is removed from the patient's vein and the catheter hub 14. The needle guard 20 encloses the sharp distal tip of the needle 12 and provides protection from becoming jammed by the needle 12 during and after retraction of the needle from the catheter hub 14. The needle guard 20 can be used with a variety of different catheters , including standard catheter connectors 14 as shown in FIGS. 2 and 4 and side port catheter connectors 24 as shown in FIGS. 3 and 5.

According to various exemplary embodiments, the needle guard 20 includes an outer member 26, an inner member 28, and an elastic clip 30. The outer and inner members 26, 28 are preferably in the form of sleeves. The outer sleeve 26 connects to the catheter connector 14 and surrounds the inner sleeve 28 and the clip 30. The inner sleeve 28 is positioned on the outer sleeve 26 and is movable in the axial direction with respect to the outer sleeve 26. The clip 30 is connected to, and has axial mobility with, the inner sleeve 28. The outer sleeve 26, inner sleeve 28 and clip 30 may be formed of a metal, elastomer, polymer or composite material. In various embodiments, the outer sleeve 26 and inner sleeve 28 are molded from a polymer material and the clip 30 is formed from a thin piece of resilient metal, such as stainless steel. The clip in the various disclosed embodiments may act as an exemplary needle protection member. The characteristics of the exemplary embodiments of FIGS. 1-6 may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

According to the exemplary embodiments illustrated in FIGS. 7A-7J, the outer sleeve 26 includes an outer surface 32, an inner surface 34, a proximal opening 36, and a distal opening 38. The outer surface 32 has an octagonal configuration with eight flat sides, although other curvilinear and or rectilinear shapes may be used. . The inner surface 34 has a flat top wall and a flat bottom wall connected by a pair of curved sides. The inner surface 34 defines a cavity for receiving the inner sleeve 28. The introducer needle 12 initially extends through the proximal and distal openings. A slot 40 extends through a wall of the outer sleeve 26. The size, shape and configuration of the outer sleeve may vary, depending on space requirements and the type of catheter connector 14.

A closure device 42 extends from the external surface to engage or interconnect with a protuberance 44 on the catheter connector 14 as best shown in FIGS. 8A-8B. This engagement occurs before the needle 12 becomes enclosed by the clip 30. In various exemplary embodiments the closure device 42 may be configured to engage any type of feature on the catheter hub 14, including a notch, slot, or hole. The modification of the closure device 42 may depend on the configuration of the catheter connector 14. In the exemplary embodiment, the protrusion of the catheter connector 44 is a Luer receiving thread, for example a LUER-LOK® thread style.

The closure device 42 has a front edge, a rear edge and a pair of side edges. An opening or depression is formed between the leading edge and the trailing edge to receive the protrusion of the catheter hub 44. The opening allows the closure device 42 to be formed with a margin approximately equal to or slightly greater than the height of the protrusion 44. , allowing the closure device 42 to be attached to the front, rear and/or side of the Luer thread protuberance 44, while minimizing the amount of material and space required. In various exemplary embodiments, the opening may be omitted. The closure device 42 resists premature release of the needle guard 20 from the catheter connector 14. The features of the exemplary embodiments of FIGS. 7A-8B may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

According to the exemplary embodiments illustrated in FIGS. 9A-9I, the inner sleeve 28 includes a base 46, a distal side 48 and a proximal side 50. An elastic leg 52 and a leg 54 extend from an external surface of the base 46. The elastic leg 52 and the leg 54 they engage the slot 40 in the outer sleeve 26. One or more clip retainers 56 extend from an inner surface of the base 46. The clip 30 is positioned between the clip retainers 56 and the proximal side 50. An opposing member 58 extends from the distal side 48 in the distal direction. The opposite member 58 is configured to be inserted into the catheter hub 14 when the needle 12 is in the exposed position (first position, for example). In the exemplary embodiment shown in FIG. 9A-9I the opposite member is a tubular member. The proximal side 50, the distal side 48 and the opposite member 58 each have an opening to receive the introducer needle 12. The size, shape and configuration of the inner sleeve 28 may vary, depending on space requirements and the catheter connector type 14 and external sleeve 26.

In an alternative embodiment of the inner sleeve 18, a bridge member (not shown) may be incorporated to improve the strength of the inner sleeve 18. Specifically, the upper surface of the distal side 48 and the upper surface of the proximal side 50 may be connected by a solid member having a similar length to the base 46. The inner sleeve 18 may be manufactured by injection molding, for example.

In another alternative embodiment, the foot 54 of the base 46 can be removed and the base 46 can be a solid member. According to this configuration, the inner sleeve 28 deforms into the outer sleeve 26 to achieve proper retention. The inner and outer sleeves 28, 26 are appropriately sized so that the inner sleeve 28 can also move axially inward and relative to the outer sleeve 26 upon application of a predetermined force. If a force less than the predetermined force is applied, the inner sleeve 28 does not move relative to the outer sleeve 26. Such a configuration improves the moldability and workability of the inner sleeve 28 and outer sleeve 26. The characteristics of exemplary embodiments of FIGS. 9A-9I may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

According to the exemplary embodiments illustrated in FIGS. 10A-10I, the elastic clip 30 includes a base 60 having an opening for receiving the needle 12, a first arm 62 and a second arm 64 extending from the base 60. The first arm 62 extends further in the axial direction than the second arm 64. The first arm 62 has a first hook 66 and the second arm 64 has a second hook 68. A first tab 70 is formed on the first arm 62 and a second tab 72 is formed on the second arm 64. The characteristics of the exemplary embodiments of FIGS.

10A-10I may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

FIGS. 11 and 12 illustrate the exemplary embodiment of the needle guard 20 in an assembled condition, FIG. 11 shows the leg 52 and leg 54 of the inner sleeve 28 positioned in the slot 40 of the outer sleeve 26. The leg 54 engages the slot 40 to resist axial movement of the inner sleeve 28 relative to the outer sleeve 26 past the point where the leg 54 engages an edge of the slot 40. The leg 52 and leg 54 may also be formed in the outer sleeve 26 with the slot 40 formed in the inner sleeve 28, FIG. 12 shows the first and second clip tabs 70, 72 engaging a first boss 74 and a second boss 76 on the outer sleeve 26. The tabs 70, 72 help prevent the clip 30 and the inner sleeve 28 from unintentionally sliding towards the external sleeve 26, for example during shipping. In the initial position, the introducer needle 12 deflects the first and second arms 62, 64 into an open position so that the tabs 70, 72 engage the outer sleeve 26.

FIGS. 13-16 illustrate another exemplary embodiment of the needle guard 78 and represent an example of the needle guard 20 in operation. Initially, the introducer needle 12 passes through the outer sleeve 80, the inner sleeve 82 and the clip 84. The introducer needle 12 deflects the clip 84 to an open position, so that the first and second hooks rest along the axis of the needle 12. In the assembled position, the closure device 86 engages the Luer thread 44 on the external surface of the catheter hub 14 and the opposite member extends towards the proximal opening of the catheter hub 14. To remove the closure device 86 of the catheter hub 14, the outer sleeve 80 of the guard 78 must be raised so that the closure device 86 can slide over the Luer thread 44. However, lifting the needle guard 78 relative to the catheter hub 14 is initially avoided, however. by the opposite member 88 that extends towards the catheter connector 14.

As the needle 12 is removed from the catheter hub 14, the tip of the needle 12 passes over the first and second hooks, causing the first and second arms to close and the first and second hooks to surround the tip of the needle 12. After the tip of the needle 12 passes the first and second hook and the first and second arms move in a closed orientation, the tab 85 disengages the outer sleeve 80 and the inner sleeve 82 can move axially further toward the outer sleeve 80 A second position may refer to the closed position, while the first position may refer to any needle position 12 before entering the second position.

As the needle 12 is pushed further, the needle shaft slides through the needle guard 78 until a deformation 90, for example a curl or protuberance formed near the distal end of the needle 12 to increase its diameter, attaches to the base of the clip as shown in FIG. 14. The opening at the base of the clip is sized to allow passage of the needle shaft, but not the deflection 90. Therefore, when the tip of the needle 12 is in the closed position of the clip 84, the deflection 90 It is also enclosed by clip 84.

Further movement of the needle 12 including deformation 90 results in the inner sleeve 82 being drawn further toward the outer sleeve 80, removing the opposite member 88 from the catheter hub 14 as shown in FIG. 15. Specifically, the inner sleeve 82 moves relative to the outer sleeve 80. When the opposite member 88 is removed from the catheter hub 14, the needle guard 78 can move radially with respect to the catheter hub 14. The Closure 86 can then be lifted from the Luer thread boss 44 and the needle guard 78, needle 12 and needle connector 16 can be separated from the catheter connector 14.

In the exemplary embodiment shown in FIGS. 11 and 12, after the needle guard 20 is removed, distal movement of the inner sleeve 28 relative to the outer sleeve 26 in the axial direction may cause the foot 54 to engage the slot 40, resisting separation. of the inner sleeve 28 and the outer sleeve 26 and possible exposure of the tip of the needle 12. The deformation engagement of the needle 90 and the base of the clip 60 prevents the needle 12 from being removed from the needle guard 20 at the proximal direction. The characteristics of the exemplary embodiments of FIGS. 11 and 12 may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

The needle guard 78 illustrated in FIGS. 13-16 is similar to the needle guard 20 shown in FIGS. 3-12. The outer sleeve 80 of the needle guard in FIGS. 13-16 includes one or more locating notches 92 extending from a rounded surface. Locating notches 92 prevent rotation of the inner sleeve 82 relative to the outer sleeve 80. The inner sleeve 82 includes a truncated connector clip retainer 94 that tapers from the proximal end to the distal end. The sides of the clip retainer 94 are configured to abut the clip 84 when in the closed orientation.

In several exemplary embodiments, the clip retainer 94 has a surface that extends so that one of the hooks rests on the clip retainer 94 (not shown) throughout the withdrawal of the needle 12. In this configuration, only one Single arm moves from open orientation to closed orientation. The use of a single movable arm reduces friction on the needle 12 and helps prevent binding during removal of the needle from the catheter hub 14. In certain embodiments, the needle guard is configured to use a clip with a single arm. , although two arms are beneficial in certain applications to balance the clip and resist tilting of the base of the clip with respect to the needle 12. The features of the exemplary embodiments of FIGS. 13-16 may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

FIGS. 17A-17C illustrate another exemplary embodiment of needle guard 96 having an outer sleeve 98 and a metal clip 100 with a single arm, omitting the inner sleeve. The outer sleeve 98 has a coupling 102 that acts as an opposing member. The coupling 102 has a first arm extending from an inner surface of the outer sleeve 98 and a second arm articulated to the first arm, for example by an elastic joint. The clip 100 includes a hook having a tab 104 that extends in the distal direction to abut the coupling 102. The tab 104 and/or the inserted needle 12 can retain the coupling 102 in the closed configuration, preventing radial movement. of the needle guard 96 with respect to the catheter connector 14 and therefore resist disengagement of the closure device from the Luer thread. As needle 12 is withdrawn toward needle guard 96, clip 100 moves to a closed position, disengaging tab 104 from coupling 102 and allowing coupling 102 to open as shown in FIG. 17B. After the coupling 102 is opened, the needle guard 96 can be disengaged from the catheter hub 14, as shown in FIG. 17C. In the closed position, the tab 104 may or may not engage a lower protuberance 106, preventing the needle 12 and metal clip 100 from exiting the needle guard 96 in the distal direction. The coupling of the deformation of the needle 90 and the base of the clip prevents the needle 12 from being removed from the needle guard 96 in the proximal direction. The characteristics of the exemplary embodiments of FIGS. 17A-17C may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

FIG. 18 illustrates another exemplary embodiment of the needle guard 108 having an outer sleeve 110 and a metal clip 112 with a single arm, omitting the inner sleeve. The clip 112 includes a hook having a tab 114 that extends in the distal direction to act as the opposite member. The tab 114 engages the inner surface of the catheter hub 14 to resist radial movement of the needle guard 108 relative to the catheter hub 14. As the needle 12 is withdrawn toward the needle guard 108, the arm moves. moves to a closed position, disengaging tab 114 from the catheter hub. This allows the needle guard 108 to disengage the catheter connector 14. In the closed position, the hook engages a lower protuberance 116, preventing the needle 12 and clip 112 from exiting the needle guard 108 in the distal direction. The coupling of the deformation of the needle 90 and the base of the clip prevents the needle 12 from being removed from the needle guard 108 in the proximal direction. The characteristics of the exemplary embodiments of FIG. 18 may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

FIGS. 19 and 20 illustrate another exemplary embodiment of the needle guard 118 having an outer sleeve 120 and a metal clip 122 with a first and second arm, omitting the inner sleeve. The first and second arms extend toward the catheter hub 14 to engage an inner surface of the catheter hub 14 and act as the opposing member. As the needle 12 is withdrawn toward the water shield, the arms move to a closed position. In certain embodiments, the closed position provides sufficient clearance for the needle guard 118 to be removed from the catheter hub 14. In alternative embodiments, the needle 12 that engages the clip 122 moves the clip 122 within the outer sleeve 120 so The first and second arms must be completely removed from the catheter hub 14 before the needle guard 118 can be disengaged.

As shown in FIG. 20, a tab 124 may extend from one of the arms. The tab 124 is inclined so that it can move proximally towards a slot 126 formed in the outer sleeve 120. The angle of the tab 124 engages one side of the slot 126 to resist distal movement of the clip 122 and the needle 12 after the needle guard 118 has been removed from the catheter connector 14. The engagement of the needle deformation 90 with the clip 122 prevents the needle 12 from being removed from the needle guard 118 in the proximal direction. The characteristics of the exemplary embodiments of FIGS. 19 and 20 may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

FIGS. 21A and 21B illustrate another exemplary embodiment of the needle guard 128 having an outer sleeve 130, an inner sleeve 132, and a clip 134 with a first and second arm. The inner sleeve 132 extends toward and abuts an inner surface of the catheter hub 14, acting as the opposing member. As the needle 12 is withdrawn toward the needle guard 128, the arms move to a closed position and the clip 134 pushes the inner sleeve 132 out of the catheter hub 14 and toward the outer sleeve 130. Disengagement of the sleeve internal 132 of the catheter connector 14 allows the needle guard 128 to be disengaged from the catheter connector 14. The features of the exemplary embodiments of FIGS. 21A and 21B may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

FIGS. 22A-22C illustrate another exemplary embodiment of the needle guard 148 having an outer sleeve 150, an inner sleeve 152, and a clip 154. The clip 154 has a first arm 156 and a second arm 158. The first arm 156 is movable and includes a hook that captures the needle 12 when the appropriate amount is drawn towards the inner sleeve 152. A protuberance 160 extends from the inner sleeve 152 to receive the second arm 158. Therefore the second arm 158 does not engage the needle during its movement . In this configuration, only the first arm 156 moves from the open orientation to the closed orientation. The use of a single movable arm reduces friction on the needle 12 and helps prevent binding during removal of the needle from the catheter hub 14. Features of the exemplary embodiments of FIGS. 22A-22C may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

FIGS. 23A-23B illustrate another exemplary embodiment of needle guard 162 having an outer sleeve 164, an inner sleeve 166, and a clip 168. The outer sleeve 164 includes a tension member 170 that extends toward and abuts the catheter hub. 14. The tension member 170 is an elastic material, for example a spring material or other elastomeric material that may be formed integrally or connected to the outer sleeve 164. In various exemplary embodiments, the tension member 170 may be formed as part of , or connect to clip 168. A housing 172 surrounds the needle guard 162. Initially, the opposite member of the inner sleeve 166, or clip 168, retains the tension member 170 in a compressed state. When the inner sleeve 166 is drawn fully toward the outer sleeve 164, the tension member 170 abuts the outer sleeve 164, assisting in moving the closure device 174 away from the Luer thread. The characteristics of the exemplary embodiments of FIGS. 23A and 23B may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

FIGS. 24A-24I illustrate another exemplary embodiment of an inner sleeve 176 having an integral or unitary clip. The inner sleeve 176 and clip combination may be made from a single piece of metal or plastic or may be made from separate pieces of material that are molded integrally together. The inner sleeve 176 includes an opposing member 180 that extends in a distal direction to enter the catheter hub (not shown) and an outer member 182 that extends in a distal direction to enter the outer sleeve (not shown ). The outer member 182 has a central cylindrical portion with one or more radially extending projections. The clip portion of the inner sleeve 176 has a first arm 184 and a second arm 186 that extend from a distal wall 188. The first and second arms 184, 186 are movable between an open and closed orientation to receive and contain the tip of a needle (not shown). The characteristics of the exemplary embodiments of FIGS. 24A-24I may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

Any of the needle guards described above may be used in connection with a multi-purpose Luer-actuated blood monitoring catheter connector as illustrated in FIGS. 25A-26F. The catheter includes a catheter hub 14 and a flexible catheter tube extending from the catheter hub. A metal wedge 136 is positioned in the catheter hub to retain the catheter tube. A septum 138 is positioned to control the flow of fluid through the catheter connector 14. As best shown in FIG. 25B, the septum 138 has one or more elastic openings or slits 140 designed to selectively prevent unwanted fluid from flowing through the septum 138. The septum 138 has three slits 140 that form three triangular flaps that open when engaged. by an actuator 142. The septum 138 is made from an elastic material, for example silicone rubber.

The septum 138 further includes a plurality of axial flow channels 139. The flow channels 139 are arranged on an outer circumference of the septum 138. Eight flow channels 139 are illustrated equidistant from each other, although various quantities and positions are contemplated. The flow channels 139 have an appropriate width and depth so that when the septum 138 is not punctured, blood can enter and air can escape from the distal end of the septum 138 at the front portion of the catheter hub. At the same time, the flow channels 139 have a size small enough to prevent blood from leaking past the septum 138 (at least for a period of time). This configuration is possible because the intermolecular forces in blood are greater than the intermolecular forces in air. The septum 138 shown in FIG. 25B can be used in any of the embodiments described herein. Other septum configurations may be used as would be understood by one skilled in the art.

An actuator 142 and a tension or return member, for example a metal or plastic compression spring 144, are positioned in the catheter hub 14. The actuator 142 engages the septum 138 to open the slots 140 and allow fluid to flow. flow through the catheter connector 14. The tension or return member 144 is capable of returning the actuator 142 to a position that allows the elastic slots 140 to close, preventing flow from flowing through the catheter connector 14.

The actuator 142 has an actuator cylinder 143A surrounding an internal passage 143B. The actuating cylinder 143A has a substantially tubular member and the internal passage 143B is substantially cylindrical. The tubular member has one or more openings 143C to allow flow to flow through and around the actuating cylinder. A first end of the actuator cylinder has a nose with a beveled external surface for engaging the septum. A truncated connector section 145A extends from the second end of the actuator cylinder 143A. The truncated connector section 145A has one or more openings 145B to allow flow to pass therethrough. A cylindrical section 145C extends from the truncated connector section 145A to engage a male Luer connector. One or more hooks having an inclined front surface and a slot 147 extend from the actuator cylinder 143A.

In the exemplary embodiment shown in FIGS. 25A-26F, the tension or return member is a spring 144, for example a helical compression spring with a distal end and a proximal end. The spring 144 may be made of metal, plastic, an elastomer, or any other suitable elastic material. The distal end of the spring 144 forms an interference fit with the inner surface of the catheter hub 14. The interference fit may be sufficient to retain the spring 144, even during loading or the distal end of the spring 144 may also abut with the septum 138. The proximal end of the spring 144 connects to the actuator 142, for example by fitting over a hook and into the slot. In other embodiments 142, the actuator 142 and the tension member 144 are combined to be a unitary structure. In various exemplary embodiments, the inner surface of the catheter connector 14 and/or the outer surface of the actuator 142 and/or tension member 144 include incisions, irregularities, projections, teeth or other structure suitable to form a fitting connection between the connector of catheter 14 and between the tension member 144, and the tension member 144 and the actuator 142.

FIGS. 26A-26F illustrate the operation of the catheter hub 14 with the actuator 142 and the tension member 144. The introducer needle 12 initially extends through the actuator 142, the septum 138, the wedge 136 and the catheter tube 22. Then After the introducer needle 12 and catheter tube 22 are inserted into a patient, the needle 12 is removed, closing the septum 138. As the male Luer connector 146 is inserted into the catheter connector 14, the Luer connector 146 stops and moves actuator 142 in the distal direction, compressing spring 144. Further insertion of Luer connector 146 moves actuator 142 through septum 138, opening slits 140 and allowing fluid to flow through the catheter connector. 14.

When the Luer connector 146 is removed, the spring 144 removes the actuator 142 from the septum 138, closing the slits 140 and preventing fluid from flowing therethrough. This allows the catheter assembly to be reused through multiple Luer connections, as opposed to a single-use catheter where the actuator 142 would remain in the septum 138 after removing a Luer connector. However, a single-use catheter without actuator 142 and/or spring 144 can also be used with the needle guards described herein. The characteristics of the exemplary embodiments of FIGS. 25A-26F may be combined with features of the other exemplary embodiments disclosed herein as appropriate.

FIG. 27 illustrates an exemplary embodiment of an actuator 254. The actuator 254 may be used in any of the embodiments disclosed herein. The actuator 254 includes a nose 258 that reduces friction when the actuator 254 penetrates a septum 238 of a catheter hub assembly. The actuator 254 further includes openings 255 that extend through the actuator 254 in a direction perpendicular to a center line of the actuator 254. For example, the actuator 254 may include two rectangular-shaped openings 255, although they are contemplated more or less.

The actuator 254 also includes a plurality of notches 257 that extend axially along the distal portion of an external surface of the actuator 254 in a plane parallel to the center line of the actuator 254. For example, four notches 257, substantially shaped radially equidistant from each other, may be present along an external surface of the distal portion of the actuator 254, although more or less notches 257 are contemplated. The notches 257 may be of various depths towards the actuator 254. The notches 257 are different from the openings 255 because the notches 257 do not extend completely through the thickness of the actuator 254.

The openings 255 and notches 257 advantageously provide an increased area for fluid to move within the catheter hub assembly. The increased area advantageously allows the discharge of fluid and prevents coagulation of fluid at the proximal and distal ends of the septum. Additionally, the openings 255 and the plurality of notches 257 advantageously minimize fluid stagnation and allow greater mixing. The notches 257 further prevent the septum from sealing to an exterior surface of the operating actuator. By not forming a sealing interface, fluid is allowed to leak through the septum through the notches 57 and provide additional discharge. FIG. 28A illustrates the actuator 254 of FIG. 27 in the catheter hub assembly. Similar to the embodiments described above, the catheter hub assembly further includes a catheter hub 214, a septum 238, and a tension member 256. As illustrated, the openings 255 and notches 257 of the actuator 254 provide more area for the fluid flows into the catheter hub 214, thereby achieving the advantages described above.

FIGS. 28B and 28C illustrate the catheter hub assembly when the tension member 256 is compressed and the actuator 254 pierces the septum 238. The catheter hub assembly may be configured so that the openings 255 and/or the notches 257 of the actuator 254 optionally pierce or penetrate septum 238. In the embodiment shown, openings 255 in actuator 254 do not penetrate septum 238. However, notches 257 in actuator 254 penetrate septum 238. This configuration allows more fluid to flow. from the proximal end to the distal end of the septum 38 through the notch 257, in addition to the advantages described above. After operation of the catheter assembly is completed, the actuator 254 is retracted from the septum 238 through the force exerted by the tension member 256. The catheter assembly is configured for multiple uses upon depression of the actuator 254. Features described in this embodiment, such as the actuator, may be used in combination with features described throughout this application.

FIG. 29A illustrates another embodiment of an actuator 364 in a catheter hub assembly. The catheter connector assembly includes a catheter connector 362 having a side port 368. The side port 368 provides secondary access to fluid flowing in the catheter connector 362. The intersection of the main recess of the catheter connector 362 and the port Side port 368 includes a sleeve 372. Sleeve 372 provides selective fluid communication between side port 368 and catheter hub 362. Specifically, when sufficient fluid pressure is applied through side port 368, sleeve 372 is compressed. Compression of sleeve 372 allows fluid to enter catheter hub 362. Reference is made to United States Patent No. 4,231,367 for a side port catheter in a catheter assembly of the type described herein. The catheter connector assembly further includes a septum 370 and a tension member 366 that provides tension to the actuator 364.

The actuator 364 includes a plurality of openings 365 that extend through the actuator 364 in a similar manner as described above. The actuator 364 includes two rows of four openings 365 that have different sizes and spacings, although various numbers, sizes and spacings of the openings 365 are contemplated. As illustrated, the openings 365 provide more area for fluid to flow into the connector. catheter 362, thus achieving similar advantages described above with respect to FIGS. 27-28C.

FIGS. 29B and 29C illustrate the catheter connector assembly when the actuator 364 pierces the septum 370 and compresses the tension member 366. The catheter connector assembly is configured so that the openings 365 of the actuator 364 optionally pierce the septum 370. In In the embodiment shown, the openings 365 in the actuator 364 do not penetrate the septum 370. This configuration allows more fluid to flow between the side port 368 and the catheter hub 362 at the proximal end of the septum 370, in addition to the advantages described previously. If the openings 365 in the actuator 364 pierce the septum 370, further fluid mixing would also occur at the distal end of the septum 370. When operation of the catheter assembly is completed, the actuator 364 retracts from the septum 370 through the force exerted by the tension member 366. The catheter assembly is configured for multiple uses upon depression of the actuator 364. The features described in this embodiment, including the actuator, may be used in combination with the features described throughout this application .

The foregoing detailed description of the exemplary embodiments has been provided for the purpose of explaining the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as appropriate for the particular use. contemplated. This description is not intended to be necessarily exhaustive or to limit the invention to the precise embodiments disclosed. Any of the embodiments and/or elements disclosed herein may be combined with each other to form various additional embodiments not specifically disclosed. Accordingly, additional embodiments are possible and are intended to be encompassed within this specification and the scope of the invention. The specification describes specific examples to achieve a more general goal that can be achieved in another way.

As used in this application, the terms "front", "rear", "top", "bottom", "up", "down" and other orientation descriptions are intended to facilitate the description of exemplary embodiments of the application. present invention and are not intended to limit the structure of the exemplary embodiments of the present invention to any particular position or orientation. Those skilled in the art understand that grade terms, such as "basically" or "approximately", refer to reasonable ranges outside the given value, for example, general tolerances associated with manufacturing, assembly and use of the described embodiments.

Claims (13)

1. A catheter assembly comprising: a flexible catheter (22); a catheter connector (14); a needle (12) having a distal tip, the needle disposed in the flexible catheter and moving from a first position exposing the needle to a second position; an external member (26) that is configured to engage and disengage from the catheter connector; an inner member (28) movably coupled and arranged on the outer member, the inner member having an opposing member (58) that engages the catheter hub when the needle is in the first position; a needle protection member (30) disposed on the inner member, the needle protection member enclosing at least a part of the needle when the needle is in the second position; in which When the needle is moved to the second position, the inner member is configured to move axially relative to the outer member causing the opposite member to disengage from the catheter hub to allow the outer member to disengage from the catheter hub. 2. The catheter assembly according to claim 1, wherein the outer member includes a slot (40) extending through a bottom wall of the outer member. 3. The catheter assembly according to claim 2, wherein the inner member includes an elastic leg (52) on a lower surface of the inner member, a distal end of the elastic leg includes a protrusion (54) that is configured to fit into the groove of the outer member. 4. The catheter assembly according to claim 3, wherein the protuberance of the inner member is coupled to the groove of the outer member in the first and second positions. 5. The catheter assembly according to claim 3, wherein the protuberance of the inner member is disposed at the distal end of the groove of the outer member when the needle is in the first position. 6. The catheter assembly according to claim 3, wherein the protuberance of the inner member is disposed at a proximal end of the groove of the outer member when the needle moves toward the second position. 7. The catheter assembly according to claim 3, wherein the elastic leg of the inner member is a cantilever arm. 8. The catheter assembly according to claim 3, wherein the groove is adjacent to a distal end of the outer member. 9. The catheter assembly according to claim 1, wherein the inner member deforms into the outer member to provide retention. 10. The catheter assembly according to claim 9, wherein the inner member moves axially in the outer member upon application of a predetermined force. 11. The catheter assembly according to claim 1, wherein the inner member includes a slot (40) extending through a bottom wall of the inner member; and the outer member includes an elastic leg (52), a distal end of the elastic leg includes a protrusion (54) that is configured to engage the groove of the inner member. 12. The catheter assembly according to claim 1, wherein the needle protection member comprises an elastic clip, the elastic clip is disposed on the inner member. 13. The catheter assembly according to claim 1, wherein the needle protection member comprises an integrally formed elastic clip.